Z-1255-2021 Class II Terminated
FDA device recall Z-1255-2021 was initiated by R & D Systems, Inc. on January 20, 2021 and is designated Class II. Reason for recall: R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and c… The recall status is terminated (terminated February 13, 2023). Affected quantity: 156 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- January 20, 2021
- Termination Date
- February 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156 kits
Product Description
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.
Reason for Recall
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
Distribution Pattern
USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
Code Information
Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604